Kornimate/medical-research-clean huggingface dataset:
validity, reliability of neck disability index in albanian

Conditions: Myofascial Pain Dysfunction Syndrome; Trigger Point Pain, Myofascial

Summary: to translate and validate the cervical disability index (ndi) into albanian for use in the albanian-speaking population

the cross-cultural adaptation will be carried out according to the internationally recommended methodology, following the guidelines: translation, back-translation; dissemination of questionnaires and data collection and analysis. psychometric properties will be assessed by administering the questionnaire to approximately 400 participants. reliability will be estimated by assessing stability and homogeneity.

Eligibility criteria:
inclusion criteria: * myofascial syndrome * headache * muscular pain * articular pain * arthirtis exclusion criteria: * contraindications to manual therapy * severe trauma * tumor * metabolic disease

Keywords: validity cross-cultural adaptation albanian neck disability index translation
evaluation of the efficacy and safety of bempedoic acid (etc-1002) 180mg, ezetimibe 10mg, and atorvastatin 20 mg triplet therapy in patients with elevated ldl-c

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to determine if triplet therapy with bempedoic acid (etc-1002) 180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients with elevated ldl cholesterol.


Eligibility criteria:
inclusion criteria: * fasting ldl-cholesterol between 130 - 189 mg/dl at screening following washout of all ldl-c-lowering drugs and nutritional supplements * men and nonpregnant, nonlactating women * sufficiently stable and suitable to undergo washout of all ldl-c-lowering drugs and nutritional supplements for 12 weeks exclusion criteria: * fasting blood triglycerides greater than or equal to 400 mg/dl * body mass index (bmi) greater than 50 kg/m2 * history of clinically significant cardiovascular disease * history of type 1 or type 2 diabetes

Keywords: hyperlididemia ldl cholesterol
efficacy and safety of ledipasvir/sofosbuvir fixed-dose combination and sofosbuvir + ribavirin for subjects with chronic hepatitis c virus (hcv) and inherited bleeding disorders

Conditions: Chronic HCV Infection

Summary: the primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (ldv/sof) fixed-dose combination (fdc) in participants with genotypes 1 and 4 hepatitis c virus (hcv) infection and sofosbuvir (sof) plus ribavirin (rbv) in participants with genotypes 2 and 3 hcv infection. participants with an inherited bleeding disorder and chronic hcv infection (either monoinfected or hiv-1/hcv coinfected) will be enrolled.


Eligibility criteria:
inclusion criteria: * hemophilia a, b or c, or von willebrand's disease * chronic genotype 1, 2, 3 or 4 hcv infection * hcv rna ≥ 1000 iu/ml at screening * use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male * screening laboratory values within defined thresholds * for hiv-1/hcv co-infected individuals: * suppressed hiv-1 rna on an antiretroviral (arv) regimen for at least 6 months prior to screening * stable protocol-approved arv regimen for \> 8 weeks prior to screening * cd4 t-cell count \> 200 cells/mm\^3 at screening exclusion criteria: * clinically-significant illness (other than hcv, inherited bleeding disorder or hiv-1) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol * current or prior history of any of the following: * hepatic decompensation * chronic liver disease of a non-hcv etiology * hepatocellular carcinoma (hcc) * infection with hepatitis b virus (hbv) * pregnant or nursing female * prior treatment with inhibitors of nonstructural protein 5a (ns5a) or the ns5b polymerase * chronic use of systemically administered immunosuppressive agents * for hiv-1/hcv co-infected individuals: * opportunistic infection within 6 months prior to screening * active, serious infection (other than hiv-1 or hcv) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline
safety and efficacy study of dexamethasone versus ranibizumab in patients with diabetic macular edema

Conditions: Macular Edema

Summary: this study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema (dme).


Eligibility criteria:
inclusion criteria: * diagnosis of type 1 or 2 diabetes mellitus * diagnosis of macular edema * visual acuity between 20/200 to 20/40 exclusion criteria: * eye surgery to the study eye within 3 months * use of ozurdex® within 9 months * any active ocular inflammation and infection * diagnosis of glaucoma * use of anti-vegf treatment (e.g., lucentis®) within 3 months in the eye or systemic use (e.g., avastin®) within 6 months
hemodynamic effects of modulating circulating ketone bodies with 1,3-butanediol

Conditions: Heart Failure

Summary: heart failure (hf) is a major public health issue affecting 1-2% of the western population and the lifetime risk of hf is 20%. despite major improvements in the management and care of patients with hf, the 1-year mortality in patients with hf is high. furthermore, patients with hf have markedly decreased physical capacity and quality of life. thus, there is a need for new treatment modalities in this group of patients. in a first-in-man study we have recently discovered that 3-ohb-infusion increases cardiac output by 2 l/min (40% relative increase) and left ventricular (lv) ejection fraction (lvef) by 8% in absolute numbers in patients with hf and reduced lvef (hfref). 1,3-butanediol (bd) serves as a potential nutritional supplement in providing long-lasting ketosis as a treatment option in heart disease. whether bd provides similar hemodynamic effects as ketone monoester remains unknown. hypothesis oral bd increases cardiac output and lv function in patients with hfref. aims to investigate the acute hemodynamic effects of weight-adjusted oral bd supplements in patients with hfref. design in a randomized, single-blind, placebo-controlled, crossover design, 12 patients with hfref are studied following overnight fast on 2 separate visits in random order: 1) during intake of bd (hvmn, san francisco, california, usa) and during placebo. methods transthoracic echocardiography, non-invasive blood pressure, and venous blood samples are obtained every 60 minutes from baseline until 6 hours following bd ingestion.


Eligibility criteria:
inclusion criteria: * chronic hf: nyha class ii-iii, lvef \<40%. negative urine-hcg for women with childbearing potential. age ≥18 years. exclusion criteria: * diabetes or hba1c \>48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give informed consent.
milta vs placebo use comparison for the management of pain related to perineal scars following delivery

Conditions: Perineal Scars; Delivery Complication; Episiotomy; Pain; Treatment

Summary: the incidence of perineal scars after a pregnancy is high, either related to an episiotomy or to spontaneous perineal tears. these perineal scars can result in acute pain but also in chronic pain for some women. medical treatment includes level 1 and 2 analgesics and, even for a few women, level 3 analgesic. the milta® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain : 1- the npcl (nano-pulsed cold laser) emissions in coherent infrared light, at 905 nanometers; 2- non-coherent emissions, pulsed by trichromatic rgb csm diodes (400 to 650 nm); 3- continuous non-coherent infrared emission monochromatic diodes at 905 nm; 4- a constant circular magnetic field (200 millitesla) equivalent to the terrestrial magnetic field and 5- the effect of magnetic tunnel which potentiates the light propagation. milta® treatment has been shown to be effective in various managements of pain, but has never been used in pain related to perineal scars. this randomized controlled trial aims at assessing milta vs placebo to reduce pain related to perineal scars after pregnancy.


Eligibility criteria:
inclusion criteria: * vaginal delivery less than 24h before inclusion * perineal scar with pain assessed as \> 3/10 with a numerical scale * 18-years-old or older * registration to the french medical system * speaking and writing french * written informed consent signed exclusion criteria: * woman under 18-years-old * woman under law liberty restriction * women unable to understand the written informed consent * no written informed consent signed * previous perineal surgery * delivery with a caesarian section * vaginal delivery with no perineal scar * vaginal delivery with infected perineal scar * women with restrictions for the use of level 1 analgesic * women requiring level 2 or 3 analgesics for other reasons

Keywords: perineal scars delivery complication episiotomy pain treatment
comfort and antimicrobial efficacy of chlorhexidine vs betadine for intravitreal injections

Conditions: Age-related Macular Degeneration; Diabetic Vascular Diseases; Proliferative Retinopathy; Retina Vein Occlusion

Summary: the purpose of this prospective interventional study is to compare patient experience, ocular surface irritation, and bacterial colony counts and microbial spectrum between povidine iodine and aqueous chlorhexidine as ocular surface antiseptic prior to intravitreal injection

this is a single center prospective study comparing antiseptic efficacy and ocular surface irritation with pi (povidine iodine) and ac (aqueous chlorhexidine). patients will be recruited in the clinical offices of the retina service of wills and hospital/mid atlantic retina clinic offices. patients who are determined to require bilateral intravitreal injections of an anti-vegf (vascular endothelial growth factor) agents by a retina specialist at their regularly scheduled retina appointment will be evaluated for qualification by study personnel. patients who meet inclusion criteria will be identified and informed consent will be obtained. prior to injection, topical anesthetic (0.5% proparacaine, alcon) will be instilled in both eyes. study personnel will obtain four samples from the superior and inferior fornices of the upper and lower lids of both eyes using swabs (copan eswab, thermofisher scientific) for patients enrolled at wills. topical antisepsis will then be applied, the first eye will be randomized to one drop of either pi 5% or ac 0.1% and the second eye will receive the other agent. one minute after instillation of the eye drop to each eye, patients will rate their pain in each eye using the wong-baker (smiley face) rating scale. the injections will then be performed by the treating retina specialist. following the injection, a second conjunctival culture will be taken in an identical manner to the first for patients enrolled at wills. study personnel will then instill fluorescein dye (fluorescein sodium ophthalmic, bioglo) into each eye, and a brief slit lamp examination will be performed. study personnel will record surface findings according to the ocular surface score and a numerical score for each eye will be determined. on post-injection day one study personnel will call the patient and ask to rate the pain in each eye using the same verbal numerical rating scale. no additional clinic visits will be required as part of the study.

Eligibility criteria:
inclusion criteria: * current patient of the wills eye hospital retina service including all mid atlantic retina offices * clinical indication of bilateral intravitreal injection as determined by the treating retina specialist for a diagnosis of age-related macular degeneration, diabetic macular edema, proliferative retinopathy or macular edema associated with retina vein occlusion. * age greater than 18. exclusion criteria: * documented allergy to pi or ac * current diagnosis of infectious keratitis * history of unilateral contact lens wear in the past 30 days * current unilateral use of prescription eye drops.
seizure detection and warning system for epilepsy patients

Conditions: Epilepsy

Summary: the seizure detection and warning system is an ambulatory system designed to monitor and analyze emg data to detect the onset of gtc seizures and to provide a warning signal to alert caregivers that a seizure is occurring.


Eligibility criteria:
inclusion criteria: 1. subject has a suspected history of gtc seizures, either primary gtc or partial onset seizures with secondary generalization. 2. is being admitted to a hospital for routine veeg monitoring related to seizures. 3. male or female between the ages of 13-21. 4. if female and of childbearing potential, has a negative pregnancy urine test, and must also not be nursing. 5. can understand and sign written informed consent, or will have a parent or a legally authorized representative (lar) who can do so, prior to the performance of any study assessments. 6. subject and/or primary caregiver must be competent to follow all study procedures. 7. is able to read, speak, and understand english or has a lar that does so. 8. subject/lar consents to the use of veeg files, including video/audio recordings, for purposes of this research study. exclusion criteria: 1. has not had a gtc seizure within the last year and is not expected to have a reduction of anti-epileptic drugs during their hospital admission. 2. intracranial eeg electrodes are being used. 3. the subject is allergic to adhesives or any component of the electrode patch assembly
translational research to inform interventions for challenging behavior

Conditions: Behavior and Behavior Mechanisms

Summary: this project is meant to identify relations between the reinforcement histories of 80 adults with intellectual and developmental disabilities (idd) and the prevalence of extinction bursts. extinction bursts, or temporary increases in rates and intensities of behavior during extinction, often preclude the inclusion of extinction in intervention packages meant to suppress severe challenging behavior, despite the fact that extinction is often necessary to generate therapeutic outcomes. study results will provide insight into how researchers can enhance interventions for the severe challenging behavior of individuals with idd while mitigating the undesirable collateral effects (i.e., extinction bursts) of therapeutic action (i.e., extinction). expanded access to study results will be made available to those who inquire after all data have been obtained and analyzed.

the goal of this project is to identify mechanisms responsible for bursts, and to facilitate strategic extensions toward discovery for treatments of challenging behavior. aim 1: in the service of this goal, the investigators aim to evaluate the accuracy of an efficient alternative to demand-curve analysis (i.e., progressive ratio reinforcer analysis) in quantifying reinforcer value (i.e., pmax). aim 2: investigators also aim to evaluate the utility of manipulating baseline reinforcement parameters for controlling bursts when those manipulations are informed by the results of demand-curve analysis.

Eligibility criteria:
inclusion criteria: * participants must be older than 18. * participants must have a developmental disability (unconstrained to specific diagnoses). * participants must be able to correctly manipulate all items used in the study. * participants must consent (or assent, when relevant) to procedures prior to and throughout the study. exclusion criteria: * participants younger than 18. * participants without disabilities. * participants who cannot correctly manipulate items used in the study. * participants who do not consent (or assent, when relevant) to participation.

Keywords: behavioral sciences reinforcement schedule motivation economics, behavioral developmental disability intellectual disability problem behavior extinction bursts
a phase 2a, dose-ranging study to evaluate the safety, pharmacokinetics and efficacy of vx-135 with ribavirin in treatment-naïve subjects with chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: the purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally administered vx-135 with ribavirin in treatment naive subjects with chronic hepatitis c infection.

up to twenty (20) subjects with chc gt1 infection will be randomized in a 1:1 ratio (with stratification by il-28b genotype (cc versus non-cc)) to evaluate vx-135 low dose or high dose both given in combination with rbv for 12 weeks. safety and tolerability will be evaluated on an ongoing basis through assessment of adverse events (aes), lab evaluations and physical examinations. subjects will be monitored from day 1 through end of follow-up for virologic breakthrough or relapse.

Eligibility criteria:
key inclusion criteria: * subjects (male and female) must be between 18-60 years of age * subjects must have chronic hepatitis c * subjects must be treatment naive * subjects must have laboratory values at screening within limits as specified by the protocol key exclusion criteria: * evidence of cirrhosis * female subjects who are pregnant or nursing or male subjects with a female partner of childbearing potential who is unwilling to adhere to the contraception requirements, is pregnant or nursing, or planning to become pregnant during the study * any other cause of significant liver disease in addition to hepatitis c * diagnosis of or suspected hepatocellular carcinoma
hvad(tm) smart 1.0 study

Conditions: Chronic Heart Failure

Summary: the purpose of hvad smart 1.0 study is to collect hvad device data (i.e., waveform + logfile + pump parameter) in various clinical conditions (e.g., routine follow-up visits, experiencing adverse events) to support development of predictive and actionable algorithms. the collected data will be used to characterize hvad flow waveform and logfile pattern changes that precede a qualifying adverse event, as well as characterize "normal" hvad flow waveform and logfile patterns (subjects free from any qualifying adverse event, any hospital readmissions related to a sae, or any parenteral medical therapy for heart failure management (e.g., inotropes, diuretics, etc.) or ultrafiltration in last 30 days). in addition, the study will collect data to evaluate the utility of carelink in hvad patients. the study will not involve any investigational testing and the market-released devices will used as per the approved labelling.


Eligibility criteria:
inclusion criteria: * greater than or equal to 18 years of age: * refractory, advanced heart failure patient that is either: prospectively identified as a candidate to receive the commercial hvad system as their first durable left ventricular assist device (lvad) implant for approved indications; or within 10 days of receiving the commercial hvad system as their first durable lvad for approved indications * patient provides written authorization and/or consent per institution and geographical requirements exclusion criteria: * patient who is, or is expected to be inaccessible for follow up * patient with previous durable mechanical circulatory support device * patient with planned bi-vad procedure * patient with exclusion criteria required by local law * patient is currently enrolled in or plans to enroll in an concurrent drug and/or device study that may confound results (i.e., no required intervention that could affect interpretation of all-around product safety and/or effectiveness). concomitant observational studies allowed if permitted by irb/ec
randomized trial of interrupted versus continuous vaginal closure of anterior repair with mesh

Conditions: Pain; Dyspareunia; Surgical Mesh

Summary: vaginal prolapse is a common condition that is treated with surgical correction. recently surgeons have been using mesh to augment the repair of vaginal prolapse. common complications of this surgery include vaginal pain, pain during sex, infection or erosion of the mesh in the vagina. there are different ways to close the vaginal wall over the mesh used in these procedures. currently, there is no accepted standard method of closing the vaginal wall. the purpose of this study is to find out the best way to close the surgical wound in the vagina. we will compare interrupted closure (separate stitches) to continuous closure (one long, running stitch). we hope to show in our study that one method of closure is better than the other.


Eligibility criteria:
inclusion criteria: * scheduled for surgery to correct anterior vaginal prolapse with mesh kit exclusion criteria: * pregnant
study of the efficacy and safety of du-176b in preventing blood clots in patients undergoing total hip replacement

Conditions: Arthroplasty, Replacement, Hip; Thrombosis

Summary: patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). this study evaluates the safety, tolerability and effectiveness of the study drug, du-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.

the primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. the secondary objective is to assess the safety and tolerability of du-176.

Eligibility criteria:
inclusion criteria: * unilateral hip replacement exclusion criteria: * patients scheduled for bilateral hip replacement in same procedure * patients with increased risk of bleeding * uncontrolled hypertension (bp greater than 180/100 mmhg) * patients less than 111 lbs or more than 243 lbs * patients on long-term anticoagulants * patients with contraindications to venography * patients with medical history of venous thromboembolism * patients with impaired hepatic function * known to be pregnant * lactating women

Keywords: deep vein thrombosis, anticoagulant, venous thromboembolic
acute hemodynamic effect of acetazolamide in pulmonary hypertension

Conditions: Hypertension, Pulmonary

Summary: to study the acute effect of acetazolamide (aza) on pulmonary hemodynamics in patients with pulmonary hypertension (ph) undergoing clinically indicated right heart catheterisation (rhc).

pulmonary hypertension (ph) of various etiologies causes dyspnea, impairs exercise performance and is associated with reduced quality of life (qol) and survival. treatment options include therapy for any underlying causes, pulmonary vasodilator drugs, oxygen and, in selected cases, pulmonary endarterectomy or lung transplantation. unfortunately, ph specific drugs are expensive, associated with side effects and even combined pharmacological treatment is often not sufficient to achieve clinical benefits. therefore, novel therapeutic drugs are needed. the investigators have recently demonstrated that sleep related breathing disorders, which are common in ph patients, can be improved by both nocturnal oxygen therapy and acetazolamide (aza). aza is a carbonic anhydrase (ca) inhibitor that acts as a respiratory stimulant thereby improving oxygenation and possibly ph. there are even data suggesting that ca-inhibitors have a direct pulmonary vasodilator effect. however, the potential role of aza in the treatment of ph has not been conclusively studied. therefore, the purpose of the current project is to investigate, the acute hemodynamic clinical effects of aza in ph patients.

Eligibility criteria:
inclusion criteria: * all patients undergoing rhc for a clinical indication and who are diagnosed with precapillary ph (mpap ≥25 mmhg, pulmonary wedge pressure (pawp) ≤15mmhg) exclusion criteria: * patients in whom a rhc is clinically not indicated * pregnant women * ph in left heart disease or with more than mild chronic obstructive pulmonary disease or restrictive lung disease.

Keywords: acetazolamide hemodynamics